FDA.reportPublic FDA data

Ritalin

Product NDC
0078-0372
11-digit product format
000780372
Labeler code
0078
Product ID
0078-0372_8f4647d0-4965-4dee-8f60-1340ef9be3de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021284
Marketing category
NDA
Marketing start
2002-06-05
Marketing end
2026-10-31
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ritalin
Brand name suffix
LA

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091143, 1091167, 1091182, 1091197, 1806177, 1806179, 1806183, 1806195

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0372-05RitalinLA100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0372-05EA - Each0078-03726f78fd97-178e-4682-94ab-1de071db3c2112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
GELATININACTIVE INGREDIENT2G86QN327LRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ARITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
TALCINACTIVE INGREDIENT7SEV7J4R1URITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0372RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]33Current NDC, Legacy NDC, 1 package rows20231030_effd952d-ac94-47bb-b107-589a4934dcca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806195methylphenidate HCl 10 MG 50/50 Release 24HR Extended Release Oral CapsulePSNeffd952d-ac94-47bb-b107-589a4934dcca36
1806177methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral CapsulePSNeffd952d-ac94-47bb-b107-589a4934dcca36
1806179methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral CapsulePSNeffd952d-ac94-47bb-b107-589a4934dcca36
1806183methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral CapsulePSNeffd952d-ac94-47bb-b107-589a4934dcca36
1091143Ritalin LA 10 MG 24HR Extended Release Oral CapsulePSNeffd952d-ac94-47bb-b107-589a4934dcca36
1091167Ritalin LA 20 MG 24HR Extended Release Oral CapsulePSNeffd952d-ac94-47bb-b107-589a4934dcca36
1091182Ritalin LA 30 MG 24HR Extended Release Oral CapsulePSNeffd952d-ac94-47bb-b107-589a4934dcca36
1091197Ritalin LA 40 MG 24HR Extended Release Oral CapsulePSNeffd952d-ac94-47bb-b107-589a4934dcca36
109114350/50 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Ritalin]SBDeffd952d-ac94-47bb-b107-589a4934dcca36
109116750/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Ritalin]SBDeffd952d-ac94-47bb-b107-589a4934dcca36
109118250/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule [Ritalin]SBDeffd952d-ac94-47bb-b107-589a4934dcca36
109119750/50 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Ritalin]SBDeffd952d-ac94-47bb-b107-589a4934dcca36
180619550/50 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCDeffd952d-ac94-47bb-b107-589a4934dcca36
180617750/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDeffd952d-ac94-47bb-b107-589a4934dcca36
180617950/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCDeffd952d-ac94-47bb-b107-589a4934dcca36
180618350/50 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCDeffd952d-ac94-47bb-b107-589a4934dcca36
1806195methylphenidate HCl 10 MG 50/50 Release 24HR Extended Release Oral CapsuleSYeffd952d-ac94-47bb-b107-589a4934dcca36
1806177methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral CapsuleSYeffd952d-ac94-47bb-b107-589a4934dcca36
1806179methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral CapsuleSYeffd952d-ac94-47bb-b107-589a4934dcca36
1806183methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral CapsuleSYeffd952d-ac94-47bb-b107-589a4934dcca36
1091143Ritalin LA 10 MG 24HR Extended Release Oral CapsuleSYeffd952d-ac94-47bb-b107-589a4934dcca36
1091167Ritalin LA 20 MG 24 HR Extended Release Oral CapsuleSYeffd952d-ac94-47bb-b107-589a4934dcca36
1091182Ritalin LA 30 MG 24HR Extended Release Oral CapsuleSYeffd952d-ac94-47bb-b107-589a4934dcca36
1091197Ritalin LA 40 MG 24HR Extended Release Oral CapsuleSYeffd952d-ac94-47bb-b107-589a4934dcca36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0372-0500078037205100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0372-05) 2002-06-052026-10-31NoNoCurrent